Injector system for encoding and sensing of syringe information

ABSTRACT

Injector systems which include a syringe and a powered injector to inject a fluid into a patient are described. The powered injector includes a drive member, an energy source, at least one sensor for detecting energy from the energy source, and at least one contact member axially movable in the injector and in communication with the sensor. The syringe includes at least one indicator positioned at a predetermined position, such as on a rear surface of an attachment flange, which may transmit or reflect energy from the energy source to the sensor. The contact member may contact and be moved by the indicator when the syringe is attached to the powered injector, so that the energy detected by the sensor may be determined by the position of the indicator. The position of the indicator thereby provides information about the syringe configuration.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a divisional application of pending U.S. patentapplication Ser. No. 12/419,019, filed Apr. 6, 2009, now U.S. Pat. No.8,439,876, issued May 14, 2013, which is a divisional application ofU.S. patent application Ser. No. 10/114,710, filed on Apr. 2, 2002, nowabandoned, which claims the benefit of U.S. Provisional Patent Appln.No. 60/281,169, filed on Apr. 3, 2001, the disclosures of which are eachincorporated herein by reference as of set forth in their entirety.

BACKGROUND OF THE INVENTION

The present invention relates to encoding and sensing of information orconfiguration, and, especially, to encoded syringes, to injectors forreading encoded syringes, to injector systems including encoded syringesand to methods of encoding and sensing syringe information.

Critical parameters of an injection procedure are determined by a numberof variables, including, for example, syringe diameter, syringe length,syringe material and fluid composition/concentration. Among the affectedinjection procedure parameters are fluid volume delivered, flow rate,fluid pressure, and limits of injector piston travel. In currentinjector systems, syringe size/volume is generally determined either (1)manually by action of an operator who enters the syringe size/volume ortype into the injector software, or (2) automatically by means ofswitches on the injector head which are mechanically coupled to raisedor sunken elements on the syringe. See, for example, U.S. Pat. Nos.5,741,232, 6,090,064 and 5,873,861, assigned to the assignee of thepresent application, the disclosures of which are incorporated herein byreference. In U.S. Pat. No. 5,873,861, the presence or absence of one ormore of detents provides a code that is representative of syringeconfiguration.

Constraints of current mechanical and electrical design, however, limitthe number of such automatic detection switches. Indeed, only limitedsyringe configurations are automatically detected with present systems.Additionally, failure of certain moving mechanisms is also a problem.For example, spillage or leakage of contrast media can result in thefailure of certain mechanisms. Moreover, certain electrical andmechanical encoding systems can significantly increase manufacturingcosts of a syringe and/or injector. Other currently available methods ofencoding and sensing syringe configuration include the placement of barcodes and corresponding sensors upon the syringe and injector,respectively, as disclosed in U.S. Pat. No. 5,997,502. Bar code systems,however, suffer from some of the same problems as the electromechanicalsystems discussed above.

As used herein, the term “syringe configuration” is used to encompassall information about a particular syringe, including, but not limitedto, information about the mechanical properties of a syringe (forexample, material, length, diameter and/or volume) as well asinformation about the contents of the syringe (for example, fluid volumeand/or composition). With the advent of new syringes, and especiallyprefilled syringes, the need to accurately encode and sense (or read)syringe configuration variables is heightened. A powered injector tocontrol the injection procedure as a function of defined syringeconfiguration/injection parameters can use the information on syringeconfiguration. Moreover, a record of data associated with an injectionprocedure may be kept, for example, to track patient treatment historyand/or to satisfy accurate billing and cost information requirementsunder managed health care. A record may be maintained of informationsuch as the type of syringe used, the amount of contrast medium used,the type of contrast medium used, the sterilization date, the expirationdate, lot codes, the properties of the contrast media, and/or otherclinically relevant information. Such information can be recordeddigitally for sharing with computerized hospital billing systems,inventory systems, control systems, etc.

SUMMARY OF THE INVENTION

In one aspect, the present invention provides a syringe for use with apowered injector to inject a fluid into a patient. The syringe includesat least a first indicator positioned on the syringe at a predeterminedposition (for example, at a predetermined axial position). Preferably,the distance between a surface (for example, a rear surface) of thefirst indicator and a reference position (for example, a predeterminedposition on the syringe or on the powered injector when the syringe isin operative connection with the powered injector) provides informationabout the syringe configuration.

In another aspect, the present invention provides a syringe including atleast one indicator including a rearward-projecting member (for example,an attachment flange) on a rear portion of the syringe. The axialposition of a rear surface of the rearward-projecting member, when thesyringe is in operative connection with (for example, attached to) thepowered injector, provides information about the syringe configuration.

In a further aspect, the present invention provides a set of a pluralityof syringes for use with a powered injector to inject a fluid into apatient. Each of the syringes includes at least a first indicatorpositioned on the syringe at a predetermined position. As describedabove, the distance between, for example, a rear surface of the firstindicator and a reference position such as a predetermined position onthe powered injector provides information about a configuration of eachsyringe. In one embodiment, the first indicator on each syringe is arear surface of an attachment flange positioned on a rearward portion ofthe syringe. The axial position of the rear surface of the attachmentflange of each syringe in this embodiment provides information about thesyringe configuration of that syringe when the syringe is in operativeconnection with the powered injector.

In general, the indicators of the present invention can be an integralpart of a syringe or can be attachable thereto. For example, one or moreindicators can be attachable to a syringe through use of an adapter asknown in the art. A number of such adapters include a syringe attachmentmechanism on a forward section thereof for attachment of a syringethereto. The adapter also includes an injector attachment mechanism on arearward section thereof to attach the adapter to an injector. Anadapter can be used, for example, to attach a syringe not suitable fordirect attachment to an injector to that injector. Adapters can also beused in the present invention to add an indicator as described above toa syringe that is otherwise suitable for attachment to an injector. Forexample, the adapter can include one or more attachment flanges having arear surface positioned to provide information on syringe configuration.In general, as use herein, the term “syringe” includes syringe/adaptercombinations.

In another aspect, the present invention provides an injector systemincluding a powered injector having a drive member and at least onesensor for detecting energy. The injector system also includes a syringehaving at least a first indicator positioned on the syringe at apredetermined position (for example, a predetermined axial position).The sensor configuration detected by the sensor is determined by theposition of the indicator when the syringe is in operative connectionwith the powered injector. The position of the indicator thus providesinformation about the syringe configuration.

In one embodiment, a rear surface of the first indicator transmitsenergy to the sensor. For example, the rear surface of the firstindicator can include an energy source to transmit energy to the sensor.The rear surface of the first indicator can also include a surface thattransmits energy to the sensor by reflecting energy from an energysource to the sensor.

In another embodiment, the powered injector includes at least onecontact member movably (for example, slidably) disposed in the injector.A surface in operative connection with the contact member transmitsenergy to the sensor. For example, the transmitting surface can be therear surface of the contact member. The contact member is positioned tocome into contact with the first indicator when the syringe is inoperative connection with the powered injector such that, for example,the axial position of the rear surface of the contact member isdetermined by the axial position of the first indicator. The rearsurface of the contact member can, for example, transmit energy to thesensor. For example, the rear surface of the contact member can includean energy source to transmit energy to the sensor. In anotherembodiment, the rear surface of the contact member includes a surface toreflect or redirect energy from an energy source to the sensor.

In several embodiments, the energy transmitted in the present inventionis light energy. Reflective surfaces (for example, a mirrored surface)can be used on the contact member or on the indicator to transmit thelight energy therefrom. The light can, for example, be transmitted tothe mirrored surface by a transmitting fiber optic cable incommunication with a light source. The mirrored surface can transmit thelight to a receiving fiber optic cable in communication with a sensor.Sensors suitable for use with light energy include photodiodes.

In several embodiments, the first indicator is a rear surface of aflange or projection on a rear portion of the syringe. The flange can,for example, also function as an attachment flange to attach the syringeto a powered injector.

In another aspect, the present invention provides a powered injector foruse with a syringe to inject a fluid into a patient. The syringeincludes at least a first indicator at a predetermined position. Theinjector includes a powered drive member and at least one sensor todetect energy. The energy detected by the sensor is determined by theposition of the indicator when the syringe is in operative connectionwith the powered injector. As discussed above, the position of theindicator thereby provides information about the syringe configuration.

As also described above, the injector can, for example, include acontact member movably (for example, slidably) disposed in the injectorin which the rear surface of the contact member transmits energy to thesensor. The contact member is positioned to come into contact with thefirst indicator when the syringe is attached to the powered injectorsuch that the position of the contact member is determined by theposition of the first indicator.

In a further aspect, the present invention provides an injection systemincluding at least one syringe having at least a first indicatorpositioned on the syringe at a predetermined position (for example, arear surface of an attachment flange on the rear of the syringe). Asdescribed above, the position of the indicator is associated withinformation about the syringe configuration. The injector system furtherincludes a powered injector including a drive member and at least afirst contact member movably disposed in the injector. The first contactmember is positioned to come into contact with the first indicator whenthe syringe is attached to the powered injector such that the positionof the first contact member or the amount of change in the position ofthe first contact member is determined by the position of the firstindicator and is thus associated with the syringe configuration.

Preferably, at least three syringe configurations are associated with atleast three corresponding positions of the first contact member. Asclear to one skilled in the art, many more syringe configuration areassociable with a corresponding number of positions of the first contactmember. Each syringe configuration can, for example, be associated witha unique range of positions of the first contact member.

In one embodiment, the powered injector includes at least one lightreflective surface in operative connection with the first contact memberand a sensor to detect light reflected from the light reflective surfaceas described above.

In another embodiment, the powered injector includes a plurality ofsensors and at least a first shutter mechanism in operative connectionwith the first contact member. Each of the sensors has an “on” state andan “off” state. The shutter mechanism includes at least one cooperatingmember to cooperate with at least one of the sensors to place the sensorin an on state or an off state. The state of each of the plurality ofsensors can, for example, provide a digital code corresponding toinformation on syringe configuration.

Preferably, the shutter mechanism includes a plurality of cooperatingmembers. In one embodiment, the sensors are optical sensors and thecooperating members are spaced opaque members operable to blocktransmission of light to the sensors.

The present invention provides, in a further aspect, an injector for usewith a syringe including at least a first indicator positioned thereon.The position of the first indicator is associated with syringeconfiguration. The injector includes a powered drive member, and atleast a first contact member movably disposed in the injector asdescribed above.

In one embodiment, the first indicator is positioned on the rear surfaceof an attachment flange of the syringe and causes the first contactmember to move in an axial direction. The first contact member can, forexample, be slidably positioned on a bushing that is rotatable about theaxis of the syringe. In this embodiment, the shutter mechanism can beattached to the first contact member and is preferably rotated intocooperation with the plurality of sensors upon rotation of the bushingto attach the syringe to the injector.

In another aspect, the present invention provides a method of readingsyringe configuration information from a syringe for use with a poweredinjector. The method includes (1) positioning at least a first indicatorat a predetermined position on the syringe, (2) transmitting energy froma position determined by the indicator to a sensor on the poweredinjector, and (3) measuring an output from the sensor and correlatingthe output to a state distance defined by a distance between the firstindicator and a known position on the injector. The state distanceprovides information of the syringe configuration.

In still a further aspect, the present invention provides a method ofreading syringe configuration information from a syringe for use with apowered injector. The method includes (1) positioning at least a firstindicator at a predetermined position on the syringe, (2) contacting theindicator with at least a first contact member movably disposed in theinjector so that the position of the first contact member is determinedby the position of the first indicator, and (3) associating the positionof the contact member with syringe configuration. Preferably, at leastthree different syringe configurations are associated with at leastthree corresponding positions of the first contact member.

In one embodiment, the method includes the step of transmitting lightenergy from a surface in operative connection with the first contactmember to a sensor. The light energy measured by the sensor correspondsto the position of the first contact member.

In another embodiment, a shutter mechanism in operative connection withthe first contact member moves with motion of the contact member to aposition that determines a state of each of a plurality of sensorshaving an on state and an off state. The state of each of the pluralityof sensors provides or corresponds to a digital code corresponding toinformation on syringe configuration.

The encoded syringes, the injectors, the injectors systems, and themethods of the present invention are well suited for use in a magneticresonance environment in which care must be taken to prevent failure ofthe encoding system or device and to prevent interference with themagnetic resonance imaging equipment. In that regard, the strongmagnetic field in a magnetic resonance environment can adversely affectcertain types of devices such as electromechanically activated devices.Furthermore, differences in magnetic permeability of materials withinsuch devices and induced eddy currents therein can affect thehomogeneity of the MRI magnetic field, generating image artifacts.Likewise, radio frequency energy generated by certain devices can induceunwanted artifacts upon the acquired MRI images. Such problems areeasily avoided in the syringe encoding systems, devices and methods ofthe present invention. Any energy used in the encoding systems, devicesand methods of the present invention is easily selected to preventinterference with magnetic resonance equipment as well as interferencefrom the magnetic resonance equipment. For example, light energy in theinfrared, visible or ultraviolet range of the spectrum can be used.Likewise, radio frequency energy outside of the frequency range of theMRI scanner can be used.

Moreover, currently available syringes and injectors are readilyretrofitted to incorporate the encoding systems of the present inventionwithout substantial and/or expensive modifications thereto.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a front perspective view of one embodiment of aninjector system of the present invention.

FIG. 2A illustrates a side, cross-sectional view of the injector systemof FIG. 1.

FIG. 2B illustrates a side, cross-sectional view of another embodimentof a syringe of the present invention attached to an injector.

FIG. 2C illustrates a side, cross-sectional view of another embodimentof a syringe of the present invention attached to an injector.

FIG. 2D illustrates a side, cross-sectional view of a further embodimentof a syringe of the present invention attached to an injector, in whichthe syringe includes indicators on the syringe barrel.

FIG. 3 illustrates the output signal of a photodiode as a function ofilluminance.

FIG. 4 illustrates the output signal of a photodiode as a function ofdistance.

FIG. 5 illustrates a side, cross-sectional view of another embodiment ofan injector system of the present invention.

FIG. 6A illustrates a rear perspective view of an embodiment of asyringe interface of the present invention in a disassembled or explodedstate.

FIG. 6B illustrates a rear perspective view of the syringe interface ofFIG. 6A in a partially assembled state.

FIG. 6C illustrates another rear perspective view of the syringeinterface of FIG. 6A in another partially assembled state.

FIG. 6D illustrates a rear perspective view of the syringe interface ofFIG. 6A in a fully assembled state.

FIG. 7A illustrates a rear perspective view of the syringe interface ofFIG. 6A wherein the seating bushing is illustrated in a disengagedposition (left) and rotated to an engaged position (right).

FIG. 7B illustrates a front perspective view of the syringe interface ofFIG. 6A wherein the seating bushing is illustrated in a disengagedposition (left) and rotated to an engaged position (right).

FIG. 7C illustrates a front view of the syringe interface of FIG. 6Awherein the seating bushing is illustrated in a disengaged position(left) and rotated to an engaged position (right).

FIG. 7D illustrates a front perspective view of the syringe interface ofFIG. 6A with a syringe aligned for engagement therewith and a frontperspective view of an adapter for use with the syringe interface.

FIG. 7E illustrates a rear view of the syringe interface of FIG. 6A witha syringe connected thereto.

FIG. 7F illustrates a side, cross-sectional view of the syringeinterface of FIG. 6A with a syringe connected thereto.

FIG. 8A illustrates dimensions of one embodiment of a shutter of thepresent invention as well as several states corresponding to differentshutter positions resulting from engagement of various syringe/adaptertypes.

FIG. 8B illustrates engagement of the push pin or contact pin of thesyringe interface of FIG. 6A by a syringe/adapter and tolerance analysismeasurements associated with one embodiment of a shutter.

FIG. 8C illustrates state changes associated with the shutter and sensorembodiments of FIGS. 8A and 8B.

DETAILED DESCRIPTION OF THE INVENTION

The encoding devices, encoding systems and encoding methods of thepresent invention are particularly useful in encoding information ofconfiguration for syringes and other pumping mechanisms used in medicalinjection procedures. Several representative embodiments of the presentinvention in which, for example, light energy is used in connection withsyringe encoding are discussed below.

An embodiment of a front-loading injector system 5 of the presentinvention is illustrated in FIG. 1. Injector system 5 includes a poweredinjector 10 and a syringe 20 for injection of, for example, a contrastmedium. As best illustrated in FIG. 1, injector housing 30 of injector10 preferably includes a first drive member or piston 40 therein whichcooperates with a syringe plunger 25 (see FIG. 2A) slideably disposed insyringe 20 to inject a fluid from the interior of syringe 20 into apatient.

As used herein to describe injection system 5 and other embodiments ofthe present invention, the terms “axial” or “axially” refer generallyto, for example, an axis A around which syringe 20 and piston 40 arepreferably formed (although not necessarily symmetrically therearound)and to directions collinear with or parallel to axis A. The terms“proximal” or “rearward” refer generally to an axial or a longitudinaldirection toward the end of injector housing 30 opposite the end towhich syringe 20 is mounted. The terms “distal” or “forward” refergenerally to an axial or a longitudinal direction toward a syringe tip26 of syringe 20 (from which pressurized fluid exits syringe 20). Theterm “radial” refers generally to a direction normal to an axis such asaxis A.

Syringe 20 is preferably removably connected to injector 10 asdescribed, for example, in U.S. Pat. No. 5,383,858, the disclosure ofwhich is incorporated herein by reference. In that regard, front-loadinginjector 10 can include a front portion or faceplate 60 having a firstinterface 62 formed therein. Piston 40 is reciprocally mounted withininjector 10 and is extendible through interface 62 in faceplate 60.Piston 40 can, for example, include a piston flange or head 44 to assistin forming a connection with syringe plunger 25. In the embodiment ofFIG. 1, faceplate 60 includes receiving slots 66 a and 66 b, which arepositioned opposite one another around interface 62. Receiving flanges68 a and 68 b are positioned opposite one another and between receivingslots 66 a and 66 b and extend inwardly into interface 62.

In the embodiment of FIG. 1, the rearward end of syringe 20 includes areleasable mounting mechanism such as a pair of mounting flanges 22 aand 22 b for mounting syringe 20 in a desired position relative to thefront wall of injector 10. To attach syringe 20 to injector 10, therearward end of syringe 20 is inserted into injector interface 62 suchthat mounting flanges 22 a and 22 b are inserted into receiving slots 66a and 66 b, respectively. Piston flange 44 can engage a capturemechanism on the rear of the syringe plunger (as, for example, describedin U.S. Pat. No. 5,383,858).

Once mounting flanges 22 a and 22 b are inserted into receiving slots 66a and 66 b, respectively, and piston 40 is in position to be received bythe plunger, the operator rotates syringe 20 approximately 90 degreessuch that mounting flanges 22 a and 22 b move behind and are engaged byreceiving flanges 68 a and 68 b, respectively. Injector 10 may include astop mechanism (not shown), for example, extending from at least one ofthe retaining slots 68 a and 68 b, to prevent rotation of syringe 20more than 90 degrees. A flange 28 on the rear of the syringe 20 forwardof flanges 22 a and 22 b substantially prevents injection fluid from theexterior of syringe 20 from entering injector 10. Flange 28 also assistsin ensuring secure connection of syringe 20 to injector 10 and inpositioning syringe 20 on injector 10 in a predetermined axial positionrelative to injector 10. Tactile, visual or audible feedback can beprovided to the operator via, for example, cooperating members onsyringe 20 (for example, on sealing flange 28) and injector 10 to informthe operator that a secure connection has been achieved. After securelyattaching syringe 20 to injector 10, advancing piston 40 in a forwarddirection will apply a motive force to plunger 25 to advance the plungerforward within syringe 20, thereby forcing the contents of syringe 20out of syringe tip 26 into the fluid path to the patient. Retractingpiston 40 in a rearward direction will cause the plunger to moverearward within syringe 20, thereby drawing fluid into syringe 20.

In one embodiment of the present invention, the syringe is provided withat least one indicator element and the injector is provided withcorresponding receiver(s)/sensor(s) to provide information on syringeconfiguration. A signal received by each receiver/sensor variesdepending upon the position of the indicator element(s) upon the syringeor the distance between the indicator element(s) and thedetection/reception point(s) on the injector. In the embodiment of FIGS.1 and 2A, the indicator elements on syringe 20 are the rear surfaces offlanges 22 a and 22 b.

As illustrated, for example, in FIGS. 1 and 2A, syringe 20 can bepositioned relative to injector 10 and receiver 120 a and 120 b in aknown manner or position by abutment of the rear surface of flange 28with the forward surface of injector face 60. A constant distance Y canbe provided between the rear surface of flange 28 and the forwardsurfaces of flanges 22 a and 22 b, for example, to provide for properand secure seating of flanges 22 a and 22 b behind retaining flanges 68a and 68 b (see FIG. 1, not shown in FIG. 2A) of injector 10 whensyringe 20 is securely connected to injector 10. By varying the axialthickness (represented by X for flange 22 b) of one or both of flanges22 a and 22 b, one can define various unique states that correspond tounique syringe configurations. As illustrated in FIG. 2A, the rearsurface of flange 22 b extends beyond the rear surface of the syringebarrel by a predetermined or known amount, while the rear surface offlange 22 a is generally flush with the rear surface of the syringebarrel.

In general, the syringes of the present invention can be attached to aninjector in any manner suitable to position one or more indicatorsthereof (for example, the rear surfaces of flanges 22 a and 22 b) in amanner that will result in a correct reading of syringe configuration.In the embodiment of FIG. 2A, flange 28 serves, in part, to referencethe position of syringe 20 to injector 10 and prevents syringe 20 fromtraveling too far rearward during connection to injector 10. As clear toone skilled in the art, there are many alternative manners of attachinga syringe to an injector to properly position one or more indicatorsthereon.

As shown in FIGS. 1 and 2A, the flange 28 extends around thecircumference of the syringe 20. However, the present inventioncontemplates that the flange 28 may be segmented or otherwise formed byone or more flanges, tabs or shoulder members positioned on andextending radially from the syringe 20.

FIG. 2B illustrates a syringe 20 a including two, generally opposedattachment flanges 22 aa and 22 ab (not shown in FIG. 2B) that cooperatewith spaced flanges or surfaces such as flanges 66 aa and 66 ab on aninjector 10 a to position syringe 20 a at a predetermined axial positionwith respect to injector 10 a. Flange 22 aa includes a connectingsection 23 aa that seats between spaced flanges 66 aa and 66 ab and arearward extending section 24 aa. The axial position of the rearwardsurface 26 aa of section 24 aa can be varied between different types ofsyringes to provide information on syringe configuration as describedabove. Flange 22 ab (not shown) can provide information on syringeconfiguration in a similar manner.

As also clear to one skilled in the art, the indicators of the syringesof the present invention need not be part of or connected to anattachment flange or other attachment mechanism. For example, FIG. 2Cillustrates a syringe 20 b including a circumferential attachment flange22 b that cooperates with an attachment mechanism 66 b of an injector 10b in a manner to removably attach syringe 20 b to injector 10 b. Thissystem is described in PCT Publication No. WO 01/37903, the disclosureof which is incorporated herein by reference. In this embodiment, theaxial position of the rear surface 24 ba of the syringe wall (which canbe varied among syringe types) can provide information on syringeconfiguration as described above. Additional or alternatively, on ormore uniquely positioned indicators such as flange or projection 24 bbcan be provided on a rear portion of syringe 20 b to provide informationon syringe configuration as described above.

FIG. 2D illustrates a syringe 20 c attached to, for example, injector 10c via flanges 22 ca and 22 cb in a manner described above for syringe20. In the embodiment of FIG. 2D, indicators 24 ca and 24 cb arepositioned on the syringe barrel rather than on a rear section ofsyringe 20 c. Indicators 24 ca and 24 cb can, for example, transmitenergy to receivers 120 ca and 120 cb through a transmissive flange 28 con syringe 20 c.

Returning now to the embodiment of FIGS. 1 and 2A, receivers 120 a and120 b can, for example, be fiber optic cables suitable to receive lightsignals transmitted from the rear surfaces of flanges 22 a and/or 22 b.Receiving fiber optic cables 120 a and 120 b carry the received light tosensors such as photodiodes 130 a and 130 b. The axial position ofreception points of fiber optic cables 120 a and 120 b are preferablyknown and fixed relative to flange 28. In one embodiment, photodiodesavailable from Optek of Carrolton, Tex., under product number OPF422were used.

In the embodiment of FIGS. 1 and 2A, reflective surface 23 a and 23 b(for example, a mirrored surface in the case that light energy is used)are provided on the rear surfaces of flanges 22 a and 22 b totransmit/redirect light from the rear surfaces of flanges 22 a and 22 bto receiving fiber optic cables 120 a and 120 b. In one embodiment,protected aluminum mirrors available from Edmund Industrial Optics ofBarrington, N.J., under product stock number J32-354 were used. Light isdirected toward mirrors 23 a and 23 b such that light will betransmitted to receiving fiber optic cables 120 a and 120 b. In theembodiment of FIGS. 1 and 2, split fiber optic cabling was used.Transmitting fiber optic cables 140 a and 140 b were arranged adjacentreceiving fiber optic cables 120 a and 120 b to transmit light fromlight sources 150 a and 150 b (for example, laser diodes available fromSanyo Semiconductor Corporation of Allendale, N.J., under product numberDL-3144-0) to mirrors 23 a and 23 b. Suitable fiber optic cabling isavailable, for example, from Omron of Santa Clara, Calif., under productnumber E32-DC200.

In general, the electric signal produced by a photodiode is proportionalto the illuminance (for example, in watts/cm²) of the radiant energyincident upon the photodiode. Indeed, the output signal of a photodiodeis generally linear with respect to the illuminance applied to thephotodiode junction as illustrated in FIG. 3.

The illuminance of the incident radiant energy and thus the amplitude ofthe electric signal (for example, measured current and/or voltage)produced by a photodiode is indirectly proportional to the lineardistance between the light source (mirrors 23 a and 23 b in FIG. 2A) andthe point of reception (fiber optic receivers 120 a and 120 b).Circuitry and/or software as known in the art can be used to translatethe measured signal into a syringe configuration (using, for example,one or more comparison or lookup tables). The output signal of an OptekOPF422 photodiode used in one embodiment of the present invention isillustrated as a function of distance in FIG. 4.

As clear to one skilled in the art, sensors such as photodiodes 130 aand 130 b can be placed in direct communication with the light source(mirrors 23 a and 23 b in FIG. 2A) without intervening fiber opticcabling. However, use of fiber optic cabling can facilitate retrofittingof existing injectors with the encoding system of the present invention.Moreover (and as further discussed in connection with FIG. 5 below) useof fiber optic cabling and/or other transmitting media and theassociated remote positioning of sensors and/or energy sources assistsin preventing interference from extraneous energy sources (for example,ambient light) and in removing sensors from areas in which spilled orleaked injection media (for example, imaging contrast media) can have anadverse effect upon the sensors and/or energy sources. Moreover, fiberoptic cabling can assist in positioning sensor/light source electronicsaway from the magnetic field (for example, within a shielded housing160) of MRI equipment to reduce interference with the MRI imagingequipment. Fiber optic cabling is a particularly efficient means oftransmitting light. Indeed, measurements have shown that the reflectioncoefficient from a dielectric interface within, for example, a highquality optical fiber exceeds 0.9999. See, for example, Handbook ofOptics, McGraw-Hill, p. 13-6. Furthermore, as also clear to one skilledin the art, a light or other energy source (for example, a laser or anLED) can be positioned on the rear surface of flanges 22 a and 22 brather than using reflected energy.

The number of states or configurations detectable by the encodingsystems of FIG. 2A depends, for example, upon the resolution of sensorssuch as photodiodes 130 a and 130 b. In general, photodiodes arerelatively sensitive to even small changes in the distance between thetransmittance point of the light and the reception point of the light,enabling the definition of a relatively large number of discreet statesor configurations over a relatively short distance.

The number of states or configurations detectable also depends upon thenumber of indicator/sensor parings. For example, if seven discreetstates are detectable using a single indicator/sensor pairing, 49 statesare detectable using two such pairings. Table 1 provides one embodimentof a state table for one Optek OPF422 photodiode used in the presentinvention. A disengage state and six additional states, corresponding todifferent lengths X as described above, are defined by associating orcorrelating discreet ranges of voltage output with those states.

TABLE 1 Distance (inches) Min (V) nom (V) max (V) Disengage 0.1 0.1050.11 State 1 0.13 0.135 0.14 State 2 0.16 0.165 0.17 State 3 0.19 0.1950.2 State 4 0.225 0.23 0.235 State 5 0.275 0.28 0.285 State 6 0.395 0.40.405

In addition to providing additional detectable states or configuration,multiple indicators can be provided for calibration or to provide dataintegrity. Moreover, a single sensor can be used with multipleindicators. In certain situations, it can also be desirable to pulse thetransmitted energy to improve detectability.

In the embodiment of FIG. 5, injector 10′ includes contact members suchas push pins 220 a and 220 b that are slideably disposed within injectorhousing 30′ such that they are contacted by the rear surfaces of atleast one of flanges 22 a and 22 b, respectively. Push pins 220 a and220 b are preferably biased in a forward position by, for example,springs 230 a and 230 b. In the embodiment of FIG. 5, the rear surfacesof push pins 220 a and 220 b include reflective surfaces such as mirrors223 a and 223 b as described above. Mirrors 223 a and 223 b are suitablypositioned to reflect light from light sources 150 a and 150 b exitingtransmitting fiber optic cables 140 a and 140 b to receiving fiber opticcables 120 a and 120 b and therethrough to photodiodes 130 a and 130 b.The output signal of photodiodes 130 a and 130 b is proportional to thedistance between the rear surface of push pins 220 a and 220 b andreceiving fiber optic cables 120 a and 120 b, respectively, as describedabove. The distance between the rear surface of push pins 220 a and 220b and receiving fiber optic cables 120 a and 120 b is directlyproportional to the axial position of the rear surfaces of flanges 22 aand 22 b, respectively.

Sealing members such as O-rings 240 a and 240 b can be provided tofurther assist in preventing spilled or leaked injection fluid fromcoming into contact with the optics (or other transmission and/orsensing media) used in the injectors of the present invention.

Although the indicators in the embodiment of FIGS. 1, 2A and 5 of thepresent invention have been shown to be positioned on flanges 22 a and22 b within housing 30 or housing 30′ of injector 10 or injector 10′,respectively, when syringe 20 is attached to injector 10 or injector10′, the indicators can be positioned anywhere on syringe 20 (compare,for example, FIGS. 2A through 2D). Moreover, energy sources other thanlight sources can be used in the present invention. Any energysource/sensor or receiver pairing in which the output of the sensor isproportional to the distance the energy is transmitted from theindicator is suitable for use in the present invention. For example, anywaveform type energy (for example, sonic energy or electromagneticenergy) can be used.

In case fiber optic cable is used in the above embodiments to transmitlight from an energy source to a sensor or receiver, preferably dynamicchange or deformation (for example, bending or twisting) of the fiberoptic cable is minimized. Because of the manner in which lightpropagates through fiber optic cable (that is, reflecting or bouncingbetween the sides of the cable as it passes therethrough), twistingand/or bending of the fiber optic cable changes the path of the fiberoptic cable, thereby changing the path of the light. Light beams thusmay exit the cable at different angles than for which the system wascalibrated and can cause a different amount of light to reach areceiver. If the changes are substantial, an erroneous signal canresult.

FIGS. 6A through 8B illustrate another embodiment of the presentinvention in which a syringe (or, for example, a syringe adapter asknown in the art) contacts and displaces a push pin or push pins toprovide syringe configuration or information to an injector.

As illustrated, for example, in FIGS. 6A-6D, a syringe interface ormount 400 (shown assembled, for example, in FIG. 6D) includes a push pin432 that is preferably part of or formed with a shutter mechanism 430.Alternately, the push pin 432 may be a separate part that is connectedor attached to the shutter mechanism 430. A rubber boot or seal 420 maybe placed over the push pin 432 to prevent contrast fluid or othermaterial from entering the syringe interface 400 or bushing seat 450.

When assembled, the push pin 432 (and the shutter mechanism 430)protrudes in a forward axial direction from a rear surface of arotatable bushing seat 450. In the embodiment of FIGS. 6A-8B, bushingseat 450 is rotatable within an interface housing 480 (see, for example,FIG. 6C). Interface housing 480 includes slots 482 a and 482 b throughwhich, for example, flanges 822 a and 822 b (not shown) of syringeadapter 800, to which syringe 700 is attached (illustrated, for example,in FIGS. 7D and 7F), can pass to be seated in slots 452 a and 452 b(see, for example, FIG. 7C) of bushing seat 450. After seating syringeadapter 800, syringe 700 and adapter 800 are rotated approximately ¼turn or 90° (thereby rotating bushing seat 450) relative to interfacehousing 480 so that flanges 822 a and 822 b of syringe adapter 800 arerotated behind and into cooperation with retention flanges 484 a and 484b of interface housing 480 to removably attach syringe adapter800/syringe 700 to syringe mount 400 as described above. Flange 828assists in forming a secure connection of syringe adapter 800 tointerface 400 and in ensuring the proper axial position of syringeadapter 800 relative to interface 400 as discussed above. Rotation ofbushing seat 450 relative to housing 480 as a result of the connectingmotion of syringe adapter 800 also rotates a shutter 434 of a shuttermechanism 430 into operative connection with a sensor circuit board 500(see, for example, FIG. 7E) as described below.

In general, a syringe such as a syringe 700 that is not suitable fordirect attachment to syringe interface 400 or that does not have one ormore attachment flanges that are adapted/dimensioned to provideinformation on syringe configuration can be attached to syringeinterface 400 through use of intermediate adapter 800 as describedabove. Flange 822 a, for example, is dimensioned to provide informationon the syringe configuration of syringe 700. Adapter 800 can, forexample, include a syringe attachment mechanism 860 to attach syringe700 thereto via flanges 722 a and 722 b (not shown) of syringe 700 in amanner described above. As known in the art, adapters have many types ofsyringe attachment mechanisms that can be used to adapt a wide varietyof syringes for attachment to syringe interface 400. Examples of syringeadapters suitable for use in the present invention are disclosed, forexample, in PCT Publication No. WO 01/08727, the contents of which areincorporated herein by reference.

Syringe mount 400 can provide tactile, visual or audible feedback to theoperator and to injector 10 to inform the operator that a secureconnection has been achieved. For example, bushing seat 450 can includeflexing extensions 454 that cooperates with a receptacle 486 oninterface housing 480 to provide tactile and audible feedback. In thatregard, rotation of flexing extensions 454 into and out of receptacles486 requires radial inward flexing of flexing extensions 454. Thecooperation of extensions 454 and receptacles 486 can also provideresistance to rotation of, for example, syringe adapter 800 or syringe20 and bushing seat 450 in a counterclockwise direction to releasesyringe adapter 800 or syringe 20 from cooperation with retentionflanges 484 a and 484 b (that is, toward the position of the left sideof FIGS. 7A through 7C).

As discussed above, push pin 432 is moved rearward upon contact withsyringe adapter 800 a distance determined by the axial thickness of atleast one of syringe adapter flanges 822 a or 822 b. Push pin 432 is inoperative connection with shutter assembly 430 such that axial motion ofpush pin 432 is translated to axial motion of shutter assembly 430. Inthe embodiment to FIGS. 6A through 8B, as discussed above, push pin 432preferably includes a cap or sealing member 420 seated thereon. Theassembly of push pin 432 and shutter assembly 430 are seated in arearward extending well 454 formed on the rear of bushing seat 450.Shutter 434 of shutter assembly 430 moves axially through slot 458 ofwell 456. Push pin 432 and shutter assembly 430 are preferably biased ina forward or reference position (corresponding, for example, to a statein which no syringe is connected to syringe interface 400) by, forexample, a spring 436. Spring 436 is biased against a shutter plate 438that operates to secure push pin 432 and shutter assembly 430 withinwell 454.

As discussed above, shutter 434 is linearly translated a distancedetermined by the flange length of the engaged syringe/adapter (see, forexample, FIG. 7F, showing syringe adapter 800 of type 4 from Table 2below attached to syringe interface 400). The movement of shutter 434causes blocking extensions 435 of shutter 434 to block or unblock alight source/receiver pair in each of a plurality of sensors 510 a, 510b and 510 c positioned on circuit board 500. The digital output ofsensors 510 a-c provides the configuration of the syringe or adapterthat is engaged on the injector.

Syringe interface 400 provides the ability to accurately detect (1)whether a syringe/adapter is engaged thereto as well as (2) multipledifferent syringes having different flange sizes as described above. Inthe embodiment of FIGS. 6A through 8B, three sensors 510 a-c arepreferably used to provide a maximum of eight combinations (2³=8) ofsensor on/off states to associate with syringe or adapterconfigurations. As described above, shutter 434 is rotated intocommunication with sensors 510 a-c upon engagement of a syringe oradapter. Thus, a disengaged state corresponds to the state when allthree sensors are on. All of sensors 510 a-c are preferably placed onthe same side of shutter 434 to provide for such rotation. Preferably,the state corresponding to all sensors being off is not used todetermine a syringe state because of difficulties in testability. Inthat regard, it would be difficult to determine if sensors 510 a-c wereblocked or malfunctioning in that state. Blocking extensions 435 and theopenings therebetween are preferably sufficiently wide to ensure totalactivation or deactivation of sensors 510 a-c.

Table 2 provides a representative list of syringe/adapters,corresponding flange lengths and sensor states for one embodiment of thepresent invention.

TABLE 2 Sensor State List Syringe/ Flange Adapter Length DisplacementSensor Sensor Sensor Type (in.) (in.) 510a State 510b State 510c State 10.25 0.032 Off On Off 2 0.318 0.096 Off Off On 3 0.386 0.162 On Off On 40.455 0.229 On On Off 5 0.515 0.288 Off On OnFIG. 8A illustrates the dimensions of one embodiment of shutter 434 andthe states for each of the sensors/adapters of Table 2 for a givensensor spacing.

The shutter mechanism 430 and sensors 510, in a preferred embodiment,reliably read multiple syringe and/or adapters of similar geometrywithin a given range of desired operation. A tolerance analysis wasperformed on the sensing mechanism to minimize or substantially preventmisreads. Misreads can occur, for example, if the entire “sweet spot” ofa sensor is not blocked or unblocked with respect to a specific syringestate. In several embodiments of the present invention, Omron EE-SX1103photomicrosensors available from Omron Electronics, Inc. of Schaumburg,Ill., were used as sensors 510 a-c. Further information on these sensorsis provided in the Omron Electronics, Inc. specification sheet for theEE-SX1103 photomicrosensor, the disclosure of which is incorporatedherein by reference. For those sensors, the distance between the fullyopen and fully closed state is 0.020 in. Circuit board 500 (upon whichsensors 510 a-c are mounted) is adjustable in position in the directionof the movement axis of push pin 432 to facilitate alignment.

Preferably, a mechanical calibration is performed upon installation ofsensor circuit board 500. In the embodiment of FIGS. 8A and 8B, forexample, a calibration was performed using a slug corresponding tosyringe/adapter type 1 (see Table 2) engaged on syringe interface 400(see FIG. 7D). During the calibration, the top surface of top-mostsensor 510 a is aligned with the top of shutter 434 as illustrated bythe arrow in FIG. 8A. This position biases the push pin/shutter assemblyslightly and removed tolerances from the system. (Several remainingtolerances correspond to the flange thickness on the syringes oradapters, the sensor placement and the notch/blocking extensiondimensions of shutter 434 (see FIGS. 8A and 8B)). These tolerances cancontribute to the “sweet spot” of the sensor(s) moving relative to thenotches/blocking extensions on shutter 434.

FIG. 8B illustrates representative misread plays (that is, the distancebetween a sensor sweet spot and the edge of an adjacent blockingextension 435) for a machined steel shutter assembly having thedimensions set forth in FIG. 8A. In FIG. 8B, the shutter displacementcorresponds to a syringe/adapter of type 3 engaged within syringeinterface 400. Distinct states are readily obtained and associatedtolerances indicate that misreads should not occur. FIG. 8C illustratestest results obtained. The hatched regions between states in FIG. 8Crepresent transition zones in which sensors 510 a-c were in the processof changing states.

The foregoing description and accompanying drawings set forth thepreferred embodiments of the invention at the present time. Variousmodifications, additions and alternative designs will, of course, becomeapparent to those skilled in the art in light of the foregoing teachingswithout departing from the scope of the disclosed invention. The scopeof the invention is indicated by the following claims rather than by theforegoing description. All changes and variations that come within themeaning and range of equivalency of the claims are to be embraced withintheir scope.

What is claimed is:
 1. An injector system comprising: a powered injectorcomprising a drive member, an energy source, at least one sensor incommunication with the energy source for detecting energy from theenergy source, and at least one contact member axially movable in adirection of the drive member, the at least one contact member incommunication with the at least one sensor; and a syringe comprising atleast a first indicator indicative of a syringe configuration positionedon the syringe at a predetermined position, wherein the syringeconfiguration is detectable by the at least one sensor based on thepredetermined position of the at least a first indicator when thesyringe is attached to the powered injector, wherein the at least onecontact member contacts the at least a first indicator to move the atleast one contact member when the syringe is attached to the poweredinjector such that a signal from the energy source detected by the atleast one sensor is proportional to a distance moved by the at least onecontact member to indicate the syringe configuration, and wherein a rearsurface of the first indicator transmits energy to the at least onesensor and comprises a surface that transmits energy to the at least onesensor by reflecting energy from the energy source to the at least onesensor.
 2. The injector system of claim 1, comprising a surface inoperative connection with the at least one contact member transmittingenergy to the sensor; wherein the surface is a rear surface of the atleast one contact member, wherein the rear surface of the at least onecontact member comprises a reflective surface to reflect energy from theenergy source to the at least one sensor, wherein the energy is lightenergy; and wherein the reflective surface of the contact member is amirrored surface.
 3. The injector system of claim 2, wherein the atleast a first indicator is a rear surface of an attachment flange on arear portion of the syringe.
 4. An injector system comprising: at leastone syringe comprising at least a first indicator positioned on the atleast one syringe at a predetermined position, the predeterminedposition of the at least a first indicator being associated withinformation about a syringe configuration; and a powered injectorcomprising a drive member, an energy source, at least one sensor fordetecting energy from the energy source, and at least a first contactmember axially movably disposed in the powered injector, the at least afirst contact member positioned to contact the at least a firstindicator when the at least one syringe is attached to the poweredinjector such that an axial position of the at least a first contactmember is determined by a position of the at least a first indicator,wherein a change in the axial position of the at least a first contactmember as a result of contact with the at least a first indicatorindicates the syringe configuration, and wherein an amount of energyfrom the energy source detected by the at least one sensor isproportional to an axial distance moved by the at least a first contactmember to indicate the syringe configuration; wherein the poweredinjector further comprises a plurality of sensors and at least a firstshutter mechanism in operative connection with the at least a firstcontact member, each of the plurality of sensors having an on state andan off state, the at least a first shutter mechanism comprising at leastone cooperating member to cooperate with at least one of the pluralityof sensors to place the sensor in the on state or the off state, whereineach of the on state and the off state of the plurality of sensorsprovides a digital code corresponding to information on the syringeconfiguration.
 5. The injector system of claim 4, wherein the at least afirst indicator is positioned on a rear surface of an attachment flangeof the syringe.
 6. The injector system of claim 4, wherein the at leasta first shutter mechanism comprises a plurality of cooperating members.7. The injector system of claim 6, wherein the plurality of sensors areoptical sensors and the plurality of cooperating members are spacedopaque members operable to block transmission of light to the pluralityof sensors.
 8. An injector for use with a syringe comprising at least afirst indicator positioned thereon, the position of the at least a firstindicator on the syringe being associated with a syringe configuration,the injector comprising: a drive member; an energy source; at least onesensor; at least a first contact member axially movably disposed in theinjector, the at least a first contact member positioned to contact theat least a first indicator when the syringe is in operative connectionwith the injector such that an axial position of the at least a firstcontact member is determined by a position of the at least a firstindicator, wherein a change in the axial position of the at least afirst contact member as a result of contact with the at least a firstindicator indicates the syringe configuration and wherein an amount ofenergy from the energy source detected by the at least one sensor isproportional to an axial distance moved by the at least a first contactmember to indicate the syringe configuration; a plurality of sensors;and at least a first shutter mechanism in operative connection with theat least a first contact member, each of the plurality of sensors havingan on state and an off state, the at least a first shutter mechanismcomprising at least one cooperating member to cooperate with at leastone of the plurality of sensors to place the sensor in the on state orthe off state, wherein each of the on state and the off state of theplurality of sensors provides a digital code corresponding toinformation on the syringe configuration.
 9. The injector of claim 8,wherein the at least a first shutter mechanism comprises a plurality ofcooperating members.
 10. The injector of claim 9, wherein the pluralityof sensors are optical sensors and the at least one cooperating membersare spaced opaque members operable to block transmission of light to theplurality of sensors.
 11. The injector of claim 10, wherein the at leasta first indicator is positioned on a rear surface of an attachmentflange of the syringe and causes the at least a first contact member tomove in an axial direction.
 12. The injector of claim 11, wherein the atleast a first contact member is slidably positioned on a bushing that isrotatable about an axis of the syringe.
 13. The injector of claim 12,wherein the at least a first shutter mechanism is attached to the atleast a first contact member and is rotated into cooperation with theplurality of sensors upon rotation of the bushing to attach the syringeto the injector.
 14. The injector of claim 8, wherein the at least afirst indicator is positioned on a rear surface of an attachment flangeof the syringe.